Generic Medicine Info
Indications and Dosage
Adult: Initially, 12.5 mg once daily. Max: 25 mg/day.

Pain relief
Adult: Initially, 50 mg once daily followed by daily doses of 25-50 mg. Max: 50 mg/day. Treatment duration >5days is not recommended.

Rheumatoid arthritis
Adult: 25 mg daily. Max: 25 mg/day.
Hepatic Impairment
Max: 12.5 mg/day.
Hypersensitivity. Severe renal impairment.
Special Precautions
Hepatic dysfunction, pregnancy and lactation. History of ulcer disease or GI bleeding. Elderly or debilitated patients. Prolonged treatment, smoking and alcoholism may increase risk of GI bleeding. Ischaemic heart disease.
Adverse Reactions
Mouth ulcers, chest pain, weight gain, atopic eczema, muscle cramps, diarrhoea, headache, nausea; upper respiratory tract infection, hypertension, ischaemia, dyspepsia, epigastric discomfort, heart burn, nausea, sinusitis, back pain, headache, bronchitis, urinary tract infections.
Potentially Fatal: Renal failure; nephrotoxicity; MI.
PO: C, Z (NSAIDs caused foetal ductus arteriosus premature closure, foetal renal impairment and persistent pulmonary hypertension. Avoid near term, else use lowest dose for shortest time.)
General supportive measures and clinical monitoring should be used.
Drug Interactions
Increases plasma concentrations of methotrexate and lithium. Increased nephrotoxicity when used with thiazide, loop diuretics and ACE inhibitors. May reduce efficacy of loop diuretics.
Food Interaction
High fat meals may delay time to reach peak plasma concentrations.
Mechanism of Action: Rofecoxib selectively inhibits cyclooxygenase-2 (COX-2) enzyme that is involved in the synthesis of prostaglandins. It has no significant inhibitory action on cyclooxygenase-1 (COX-1) enzymes.
Onset: 45 min.
Duration: >24 hr.
Absorption: Well absorbed from the GI tract (oral); peak plasma concentrations after 2 hr.
Distribution: Protein-binding: 85%.
Metabolism: Extensively hepatic by reduction to cis- and trans-dihydrorofecoxib.
Excretion: Urine and faeces; 17 hr (elimination T1/2 at steady state).
Store at 25°C.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
Disclaimer: This information is independently developed by MIMS based on Rofecoxib from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by
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